The purpose of this study is to provide long-term clinical safety and efficacy data for tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various degrees of renal impairment.

A Phase 4, Single-Arm Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Tenofovir Disoproxil Fumarate in Combination With Emtricitabine in HIV-1 Infected Patients Experiencing Various Degrees of Renal Impairment

To evaluate the safety and tolerability of tenofovir following administration of tenofovir disoproxil fumarate 300 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment.

The secondary objectives of this study are as follows:

To evaluate the safety and tolerability of emtricitabine following administration of emtricitabine 200 mg for 48 weeks in HIV-infected patients experiencing various degrees of renal impairment.

To evaluate the efficacy of tenofovir disoproxil fumarate in combination with emtricitabine in renally-impaired HIV-infected patients.

To evaluate the pharmacokinetics of tenofovir and emtricitabine in renally-impaired HIV-infected patients.

Eligibility

Ages Eligible for Study:

18 Years to 80 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation in the study.

HIV-1 infection

Either antiretroviral therapy-naive requiring antiretroviral treatment with HIV-1 RNA greater than 400 copies/mL or antiretroviral therapy-experienced on a stable antiretroviral regimen for at least 3 mos. with HIV-1 RNA less than or equal to 50 copies/mL at screening.

No active opportunistic infection within 45 days prior to baseline.

Able to understand and sign the informed consent form and comply with the study.

Stable renal impairment within the four defined groups for at least 3 mos., based on creatinine clearance (Cockcroft-Gault method).

Exclusion Criteria:

Patients who meet any of the following are not to be enrolled in this study.

Women of childbearing potential who are unwilling to use an effective contraceptive method during the study

Contraindications to tenofovir DF, emtricitabine or efavirenz

Undergoing treatment for tuberculosis

Using atazanavir

Prior history of mutation M184V, K65R or T69 insertion

Z-score on pre-baseline DEXA scan less than -2.5

The following laboratory values within 30 days prior to study entry: *absolute neutrophil count (ANC) less than 750/mm3, *hemoglobin less than 9.0 g/dL, *platelet count less than 50,000/mm3, *AST (SGOT) or ALT (SGPT) less than 5 x ULN and *CD4 cell count less than 100/mm3.

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106379